FDA Inspection 702009 — Hurley Medical Center IRB
The FDA completed an inspection of Hurley Medical Center IRB on December 15, 2010 in Flint, MI. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 6 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- December 15, 2010
- Fiscal Year
- 2011
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Flint, MI (United States)
Additional Details
IRB
Citations
| ID | CFR | Description |
|---|---|---|
| 7293 | 21 CFR 56.109(f) | Continuing review |
| 7317 | 21 CFR 56.115(a)(1) | Copies of all research proposals and related documents |
| 7334 | 21 CFR 56.115(a)(5) | List of members |
| 7335 | 21 CFR 56.115(a)(6) | Written procedures per 56.108(a) and (b) |
| 7369 | 21 CFR 56.109(h) | Children as subjects |
| 7371 | 21 CFR 56.108(a)(1) | Reporting findings and actions to investigator/institution |